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Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC

NCT06554613 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-05-05

No results posted yet for this study

Summary

Clinical Trial

The objective of this clinical trial is to determine whether antidepressant medications, such as olanzapine, in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone. The main questions it aims to answer are:

Is the combination therapy of antidepressant medication with immune checkpoint inhibitors more efficacious than the therapy with immune checkpoint inhibitors alone? What medical issues might participants encounter when treated with the combination of antidepressant medication and immune checkpoint inhibitors?

Participants will:

Take olanzapine in combination with immune checkpoint inhibitors or immune checkpoint inhibitors alone for 2 months.

Visit the clinic for check-ups and tests every two weeks, and have follow-up visits every six weeks after the treatment ends.

Keep a record of their symptoms and disease progression.

Conditions

Interventions

DRUG

Olanzapine

Olanzapine 5mg qd (once daily), q3w(every 3 weeks), oral therapy，Administered continuously for 6-8 weeks.

DRUG

Nivolumab

Nivolumab，Infused intravenously once every 3 weeks at a dose of 2mg/kg, with a continuous 21-day treatment period constituting one treatment cycle.

Sponsors & Collaborators

  • Second Affiliated Hospital of Nanchang University

    lead OTHER

Principal Investigators

  • Lin Chuyang, Director · Nanchang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2026-12-01
Completion
2027-05-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554613 on ClinicalTrials.gov